Renal Denervation for High Blood Pressure

N/A

Waitlist Available

Led By Raymond Townsend, MD

Research Sponsored by Medtronic Vascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.

Be older than 18 years old

Must not have

Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.

Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 1 month post-procedure (6 months for new renal artery stenosis)

Summary

This trial is testing whether a kidney surgery can lower blood pressure when done alongside other blood pressure medications.

Who is the study for?

This trial is for adults with high blood pressure (140-170 mmHg over 24 hours, or office SBP of 150-180 mmHg and DBP ≥ 90 mmHg) while on up to three blood pressure medications. It's not for those with severe kidney issues, recent heart problems, certain vascular conditions, poor renal anatomy, chronic pain treated with NSAIDs often, pregnant/nursing women, uncontrolled diabetes, orthostatic hypotension or night shift workers.

What is being tested?

The SPYRAL HTN-ON MED Study is testing if the Symplicity Spyral™ renal denervation system can safely lower blood pressure compared to a sham procedure in patients already taking up to three antihypertensive drugs.

What are the potential side effects?

Potential side effects may include reactions related to the catheter-based procedure such as bleeding or bruising at the access site, damage to the kidney arteries or nerves around them; however specific risks will be detailed by study staff.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood pressure is high even though I am on 1-3 blood pressure medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need oxygen or a ventilator to breathe, not just for sleep apnea at night.

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I have type 1 diabetes or my type 2 diabetes is not well-controlled.

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I have experienced dizziness upon standing up.

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I have had heart issues or a stroke within the last 3 months or have atrial fibrillation.

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My kidney arteries are not suitable for the procedure.

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I have high blood pressure in the lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 1 month post-procedure (6 months for new renal artery stenosis)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 1 month post-procedure (6 months for new renal artery stenosis)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 1 month post-procedure (6 months for new renal artery stenosis) for reporting.